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Recent Advances in Chromatography for Pharmaceutical Analysis
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Recent Advances in Chromatography for Pharmaceutical Analysis

A special issue of Molecules (ISSN 1420-3049). This special issue belongs to the section "Analytical Chemistry".

Deadline for manuscript submissions: 31 October 2025 | Viewed by 2230

Special Issue Editor

Dr. Yannis Dotsikas

E-Mail Website
Guest Editor
Laboratory of Pharmaceutical Analysis, Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 157 84 Athens, Greece
Interests: pharmaceutical bioanalysis; drug analysis in formulations; mass spectrometry; experimental design; dried blood spots; newborn screening
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Chromatography remains a cornerstone of pharmaceutical analysis, with recent advancements greatly enhancing its applications across diverse areas such as drug analysis, bioanalysis/pharmacokinetics, natural products, metabolomics, formulations, and nanotechnology. These innovations have improved efficiency, sensitivity, and sustainability while expanding the field’s scope.

This Special Issue aims to highlight recent progress and emerging trends in chromatography, focusing on techniques such as HPLC, UHPLC, GC, HPTLC, and SFC, coupled with various detectors. We welcome contributions exploring the following topics:

  • The drug analysis of chemical drugs and their formulations.
  • The analysis of biological drugs.
  • Bioanalytical applications in biological media, including pharmacokinetics, toxicology, metabolomics, proteomics, and anti-doping studies.
  • Advances in stationary phases for pharmaceutical applications.
  • Natural product research and applications.
  • Eco-friendly and sustainable approaches in pharmaceutical analysis.
  • The integration of experimental design and artificial intelligence (AI).
  • Miniaturization and microfluidic chromatography.

We encourage all researchers to submit original research and review articles that provide significant updates on the utilization of chromatography in pharmaceutical analysis.

We look forward to receiving your contributions and advancing the field together through this Special Issue.

Dr. Yannis Dotsikas
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Molecules is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2700 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • drug analysis of chemical and biological drugs
  • bioanalysis
  • natural products analysis
  • green chemistry
  • experimental design
  • artificial intelligence
  • metabolomics
  • stationary phase

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Published Papers (4 papers)

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Research

14 pages, 752 KiB  
Article
Versatile High-Performance Liquid Chromatography and Ultraviolet Detection-Based Method for the Determination of Thioproline in Pharmaceutical and Cosmetic Products
by Marta Gaweł, Martyna Płodzik, Rafał Głowacki and Justyna Piechocka
Molecules 2025, 30(15), 3152; https://doi.org/10.3390/molecules30153152 - 28 Jul 2025
Viewed by 322
Abstract
The article presents the first method based on high-performance liquid chromatography and ultraviolet detection (HPLC-UV) for the determination of timonacic (thioproline, 1,3-thiazolidine-4-carboxylic acid, tPro) in pharmaceutical tablets and face care products (creams, sera, foundations, suncreams). Sample preparation primarily involves solid-liquid extraction (SLE) of [...] Read more.
The article presents the first method based on high-performance liquid chromatography and ultraviolet detection (HPLC-UV) for the determination of timonacic (thioproline, 1,3-thiazolidine-4-carboxylic acid, tPro) in pharmaceutical tablets and face care products (creams, sera, foundations, suncreams). Sample preparation primarily involves solid-liquid extraction (SLE) of tPro with 0.2 mol/L phosphate buffer pH 6, derivatization with 0.25 mol/L 2-chloro-1-methylquinolinium tetrafluoroborate (CMQT), followed by polytetrafluoroethylene (PTFE) membrane filtration. The chromatographic separation of the stable UV-absorbing 2-S-quinolinium derivative is achieved within 14 min at 25 °C on a Zorbax SB-C18 (150 × 4.6 mm, 5 µm) column using gradient elution. The eluent consists of 0.1 mol/L trichloroacetic acid (TCA), pH 1.7, in a mixture with acetonitrile (ACN) delivered at a flow rate of 1 mL/min. The analyte is quantified by monitoring at 348 nm. The assay linearity was observed within 0.5–125 μmol/L. The limit of quantification (LOQ) was found to be 0.5 μmol/L. The accuracy ranged from 93.22% to 104.31% and 97.38% to 103.48%, while precision varied from 0.30% to 11.23% and 1.13% to 9.64% for intra- and inter-assay measurements, respectively. The method was successfully applied to commercially available on the Polish market pharmaceutical and cosmetic products. Full article
(This article belongs to the Special Issue Recent Advances in Chromatography for Pharmaceutical Analysis)
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22 pages, 1892 KiB  
Article
Therapeutic Drug Monitoring of Everolimus Using Volumetric Absorptive Microsampling and Quantitative Dried Blood Spot Methods with LC-MS/MS in Adult Solid Organ Transplant Recipients: An Analytical and Clinical Comparative Study
by Arkadiusz Kocur, Bartosz Olkowski, Mateusz Moczulski, Dorota Miszewska-Szyszkowska, Olga Maria Rostkowska, Katarzyna Polak, Katarzyna Korniluk, Teresa Bączkowska, Magdalena Durlik and Tomasz Pawiński
Molecules 2025, 30(15), 3139; https://doi.org/10.3390/molecules30153139 - 26 Jul 2025
Viewed by 444
Abstract
Everolimus (EVE), an mTOR inhibitor, is widely used in solid organ transplantation (SOT) because of its immunosuppressive properties. Due to its narrow therapeutic window and significant pharmacokinetic variability, therapeutic drug monitoring (TDM) is essential for achieving optimal outcomes. We developed and thoroughly validated [...] Read more.
Everolimus (EVE), an mTOR inhibitor, is widely used in solid organ transplantation (SOT) because of its immunosuppressive properties. Due to its narrow therapeutic window and significant pharmacokinetic variability, therapeutic drug monitoring (TDM) is essential for achieving optimal outcomes. We developed and thoroughly validated a robust LC-MS/MS method to measure EVE levels in venous whole blood (WB) and capillary blood collected using two microsampling devices: Mitra™ (volumetric absorptive microsampling, VAMS) and Capitainer® (quantitative dried blood spot, qDBS). The validation followed EMA and IATDMCT guidelines, assessing linearity (1.27–64.80 ng/mL for WB and 0.50–60 ng/mL for VAMS/qDBS), as well as selectivity, accuracy, precision, matrix effects, recovery, stability, and incurred sample reanalysis. Clinical validation involved 66 matched samples from 33 adult SOT recipients. The method demonstrated high accuracy and precision across all matrices, with no significant carryover or matrix interference. Statistical analysis using Passing–Bablok regression and Bland–Altman plots showed excellent agreement between the microsampling methods and the venous reference. Hematocrit effects were tested both in laboratory conditions and on clinical samples and were found to be negligible. This study provides the first comprehensive analytical and clinical validation of the Mitra and Capitainer devices for EVE monitoring. The validated LC-MS/MS microsampling method supports decentralized, patient-centred TDM, offering a reliable alternative to conventional blood sampling in transplant care. Full article
(This article belongs to the Special Issue Recent Advances in Chromatography for Pharmaceutical Analysis)
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16 pages, 1409 KiB  
Article
Development and Validation of a Stability-Indicating RP-HPLC Method for Edaravone Quantification
by Riuna O’Neill, Okhee Yoo, Philip Burcham, Minh Nguyen and Lee Yong Lim
Molecules 2025, 30(13), 2866; https://doi.org/10.3390/molecules30132866 - 5 Jul 2025
Viewed by 552
Abstract
Edaravone is used to treat motor neurone disease (MND) by slowing disease progression and prolonging survival time. Currently, it is available as an IV infusion (Radicava®, Jersey City, NJ, USA) and an oral liquid suspension (Radicava ORS®, Jersey City, [...] Read more.
Edaravone is used to treat motor neurone disease (MND) by slowing disease progression and prolonging survival time. Currently, it is available as an IV infusion (Radicava®, Jersey City, NJ, USA) and an oral liquid suspension (Radicava ORS®, Jersey City, NJ, USA). Development of novel edaravone formulations is still an active field of research that requires a validated stability-indicating assay capable of providing specific, precise, and accurate quantification of edaravone content. In this study, we developed and validated a stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method for edaravone quantification. Ten RP-HPLC methods based on the previously published literature were evaluated during method development. The optimal method employed a gradient method on an Agilent ZORBAX Extend-C18 column (150 × 4.6 mm, 5 µm) and produced a sharp and symmetrical drug peak. The method was further validated according to ICH Q2(R2) guidelines for specificity, linearity, sensitivity, accuracy, and precision. Successful separation of edaravone from void signals and degradant products was achieved. The method was precise and accurate at the concentration range of 6.8–68.6 µg/mL and was recommended to use without methyl hydroxybenzoate (MHB) as an internal standard. Full article
(This article belongs to the Special Issue Recent Advances in Chromatography for Pharmaceutical Analysis)
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23 pages, 4389 KiB  
Article
On the Stability of Steroids upon Gamma and E-Beam Irradiation and the Protective Effect of Inert Conditions
by Quinten Speleers, Anke Meyers, Homaira Rashid, Yannick Dubbelboer, Elias Vanneste, Bart Croonenborghs, Annick Gillet, Aaron DeMent, Ann Van Schepdael and Erik Haghedooren
Molecules 2025, 30(12), 2605; https://doi.org/10.3390/molecules30122605 - 16 Jun 2025
Viewed by 474
Abstract
The sterility of ophthalmic drugs is a fundamental requirement for ensuring patient safety, and as such, it is subject to stringent regulatory standards. However, significant gaps remain regarding the effect of sterilization techniques on the impurity profile and relative content of active pharmaceutical [...] Read more.
The sterility of ophthalmic drugs is a fundamental requirement for ensuring patient safety, and as such, it is subject to stringent regulatory standards. However, significant gaps remain regarding the effect of sterilization techniques on the impurity profile and relative content of active pharmaceutical ingredients (API). Previous research involving a set of five APIs used in ophthalmic preparations (dexamethasone, methylprednisolone, aciclovir, tetracycline hydrochloride, and triamcinolone) demonstrated that gamma irradiation led to the formation of specific impurities in the corticosteroids, dexamethasone and methylprednisolone. This study aims to further explore the effect of both gamma and electron beam (E-beam) irradiation on the impurity profiles of these APIs under varying conditions, with and without dry ice. The analyses were conducted using high-performance liquid chromatography with ultraviolet/visible light (UV/VIS) detection and the effect of sterilization conditions was assessed in accordance with the assay and related substances test outlined in the European Pharmacopoeia (Ph. Eur.). Additionally, this study investigated whether exposure in a controlled atmosphere with reduced oxygen or water content could mitigate the formation of impurities and influence the stability of the compounds. The results indicated a protective effect of low-temperature and low-oxygen environments during both gamma and E-beam irradiation but no effect of dry conditions. Full article
(This article belongs to the Special Issue Recent Advances in Chromatography for Pharmaceutical Analysis)
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